Personnel in a sterilization station, such as the Central Service Room (CSR) or the Sterile Processing Department (SPD) of hospitals, are commonly charged with the responsibility of packaging surgical supplies to ensure that the sterility of the packaged contents is maintained from completion of sterilization to the point of reuse. Several activities are involved in the task of sterile supply delivery to the operating room and other units, such as a cardiac catheterization lab, emergency room, labor and delivery room, intensive care unit, pediatric care unit, specialized burn care units, and other surgical or medical units.
Many of the surgical instruments and supplies used in an operating room (OR), or other surgical or medical unit, are reusable. These supplies typically include such things as clamps, scalpel blade handles, retractors, forceps, scissors, surgeon's towels, basins, and the like. All of these supplies must be collected after each procedure, decontaminated, washed and dried before placing into a sterilization packaging system, and sterilized before they can be used again in another procedure. The sterilization packaging systems used must be of the size and shape to accommodate the items to be sterilized, must be compatible with and withstand the physical conditions of the sterilization process, and must be capable of maintaining the sterility of their contents post-sterilization.
Typical means of sterilizing instruments include, among others, autoclaving with steam, exposure to ethylene oxide gas, and exposure to hydrogen peroxide plasma, as is done with the STERRAD® Sterilization System from Advanced Sterilization Products, Irvine, Calif. or as done with V-PRO® Low Temperature Sterilization Systems using Vaporized Hydrogen Peroxide (VHP®). After the package and its contents have been sterilized, the sterilization package typically is stored until it is needed for a surgical or other medical procedure.
Common sterilization packaging systems include sealable pouches, sterilization wraps, and rigid containers. As an example, a rigid sterilization container will permit the entry of sterilizing vapor/gas or other medium to sterilize the contents of the container while denying the ingress of contaminants such as bacteria and other infection causing materials or their vehicles after sterilization. As such, rigid sterilization containers generally provide a consistent barrier against the ingress of contaminants. Typical rigid containers have a base and a lid with a locking mechanism and a filtered port-opening, which may include natural or synthetic filter media (woven, non-woven, polytetrafluoroethylene (PTFE), etc.), valves, a MircoStop labyrinth, etc., where the sterilant ingresses and egresses. In such current designs, the rigid container's lid has an outer edge that covers the base by extending and projecting downwards over a lip of the base. A gasket is secured inside the lid and creates a seal by mating with the lip of the base. A good seal in a typical rigid container thus requires the base's lip and the lid to maintain their shape, which is linked to conformity and fit of the gasket to the base's lip. The conformity and fit of the gasket to the lip can change over time as the lid and base are exposed to repeated forces, e.g., from normal handling, that may create dents, cuts, and scratches in the lid and/or base and cause them to become misshapen. Further, most current rigid containers utilize a dual latching mechanism, i.e., a latch or lock on each end of the container, which does not adequately distribute the closure force along the four sides of the container. Additionally, typical rigid containers do not include means for a user to gauge confidence in the integrity of the seal between the base and lid, i.e., without opening the container, it is difficult to detect if the seal of a typical rigid container has been properly formed and maintained throughout a sterilization cycle and post-sterilization.
Consequently, there is a need for a sterilization container that overcomes the shortcomings of known containers. In particular, a sterilization container that maintains the conformity and fit of a gasket that seals an interface between a body and a lid of the sterilization container would be desirable. Further, a closure mechanism that adequately and uniformly distributes a closing force along the gasket would be beneficial. In addition, an indicator for relatively quickly indicating to a user whether a sterilization container is or is not properly sealed, without requiring the user to open the container, would be advantageous. For example, sterilization container incorporating a visual seal indicator, such as a color indicator that provides a user with confidence that the container is uniformly sealed, would be useful.